QA Lead, Equipment & Metrology — GMP/MedDevice

Terrestrial Bio, Inc.; Woburn (MA); Hybrid; USD 100,000 - 140,000; Full time

Job summary

Terrestrial Bio, Inc. is seeking a Quality Assurance Engineer Lead/Manager to oversee the Equipment and Metrology program for its GLP-1 therapy platform. You will manage calibration, maintenance, and qualification of critical equipment and instruments to ensure cGMP compliance.

Reporting to the Head of Quality and Compliance, you will collaborate with Manufacturing, Process Development, QC and Facilities, lead CAPAs, and author SOPs and IQ/OQ/PQ protocols. Onsite in MA with hybrid options.

Qualifications

• BS in Mechanical, Electrical, Chemical engineering or physics, or related field.
• 6+ years (MS 3+ years) in a regulated manufacturing environment (Pharma/Biotech/Medical Device).
• Strong mechanical skills and knowledge of analytical instrumentation and equipment.
• Working knowledge of cGMP and ISO/IEC17025.

Responsibilities

• Oversee calibration schedules and procedures for equipment and instrumentation used in manufacturing and testing.
• Lead root cause investigations and CAPA for deviations.
• Author, review, approve, and revise SOPs and equipment protocols (IQ/OQ/PQ).
• Act as SME on calibration and preventive maintenance with Facilities and QC.

Skills

Mechanical aptitude

Analytical instrumentation knowledge

Measurement systems

Cross-functional collaboration

Education

BS in Mechanical Engineering, Electrical Eng., Chemical Eng., Physics or related

MS in related field (optional)

Tools

SOP writing

IQ/OQ/PQ protocols

cGMP guidance

ISO/IEC17025 knowledge

Job description

Terrestrial Bio, Inc. is seeking a Quality Assurance Engineer Lead/Manager to oversee the Equipment and Metrology program for its GLP-1 therapy platform. You will manage calibration, maintenance, and qualification of critical equipment and instruments to ensure cGMP compliance.

Reporting to the Head of Quality and Compliance, you will collaborate with Manufacturing, Process Development, QC and Facilities, lead CAPAs, and author SOPs and IQ/OQ/PQ protocols. Onsite in MA with hybrid options.